MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES STEALTH® CLAMPS; CLAMP, VASCULAR

Model Number	A3213
Medical Device Problem Codes	Material Twisted/Bent (2981); Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: unknown.Event description: hospital: [hospital name]: complaint 1 of 3: (b)(4), complaint 2 of 3: (b)(4), complaint 3 of 3: (b)(4).The product did not work as it should.When the closing movement is made, the ends do not match.See pictures for more detail.No patient was involved as it was detected prior to surgery.Type of intervention: ni.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed a slight wobble in the box lock and that the jaws were slightly misaligned.Based on the condition of the returned unit, it is likely that the reported event was caused by the box lock being loose, most likely due to wear and tear on the device.Applied medical has performed a historical trend analysis and review of production records and no trends were identified.Corrections were performed to section h6.
Event or Problem Description
Procedure performed: unknown.Event description: complaint 1 of 3: (b)(4), complaint 2 of 3: (b)(4), complaint 3 of 3: (b)(4).The product did not work as it should.When the closing movement is made, the ends do not match.See pictures for more detail.No patient was involved as it was detected prior to surgery.Additional information received from company rep: the surgeon experienced loss of occlusion due to jaw scissoring.100% of scissoring occurred.Without clamping it was correct at first glance, when clamped the jaws were twisted and lost their hold.Additional information received from applied medical: according to what i have been told, the first two had problems during the surgery.The third one was tested before surgery and that's when they saw the same problem.Type of intervention: ni.Patient status: no patient injury.

• Brand Name: STEALTH® CLAMPS
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 21193255
• Report Number: 2027111-2025-00323
• Device Sequence Number: 14332096
• Product Code: DXC
• UDI-Device Identifier: 00607915112691
• UDI-Public: (01)00607915112691
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K950492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A3213
• Device Catalogue Number: 100792801
• Device Lot Number: 1518015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown